CellCarta, a global CRO laboratory supporting the biopharmaceutical industry, announced a strategic collaboration with Tempus AI, Inc. Under the agreement, CellCarta will include Tempus in its CDx Commercialization Lab Network as the network's second commercial laboratory partner, strengthening oncology-focused companion diagnostics offerings to biopharma sponsors.
Within the CellCarta network, the collaboration gives biopharma sponsors a more direct route from companion diagnostic development and regulatory approval to commercial use in U.S. oncology practice. CellCarta develops and validates the CDx, generates the analytical and clinical evidence package, supports regulatory submissions, and performs centralized immunohistochemistry (IHC) and tissue-based testing. For sponsors within the CellCarta CDx Commercialization Lab Network, Tempus will support provider test ordering through Tempus Hub, routing sample testing to CellCarta and transmitting results back to ordering healthcare providers.
Tempus joins Sonic Healthcare USA as the second member of CellCarta's CDx Commercialization Lab Network, expanding the network's specialized oncology capabilities alongside Sonic's broad clinical and anatomic pathology reach across multiple disease areas. The Lab Network is part of CellCarta's CDx Accelerator Model, a flexible and modular framework organized around four stages: Build, Validate, Launch, and Transfer. Sponsors can engage CellCarta at the stage that fits their program—from assay development and validation through clinical deployment and regulatory submission. Following approval, CellCarta activates its Commercialization Lab Network partners, such as Tempus and Sonic, to support commercial launch strategies.
"Tempus materially strengthens the oncology dimension of our commercialization model," said Ehab A. El-Gabry, MD, Chief Medical Officer and Head of Companion Diagnostics at CellCarta. "Sponsors can develop and validate a companion diagnostic at CellCarta, pursue a single-site approval strategy through our flexible and modular CDx Accelerator Model, and then use an established oncology diagnostics platform to support physician access and ordering. This connects regulatory execution with the realities of commercial launch."
"Biopharma sponsors should not have to choose between the speed and control of a centralized CDx strategy and a credible path to physicians and patients," said Christopher Ung, Chief Scientific Business Officer of CellCarta. "Adding Tempus to our network creates a powerful route into U.S. oncology practice. It gives sponsors a practical commercialization channel from a company that oncologists already know and use, while CellCarta maintains continuity from development and regulatory approval through testing."
